Evaluation of the CapScan Device to Measure the Metabolism of Sulfasalazine

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: CapScan intestinal sampling device

• Registration Number: NCT05749068
• Lead Sponsor: Envivo Bio Inc

Brief Summary

Evaluation of the CapScan intestinal collection device in characterizing the metabolism of sulfasalazine in the digestive tracts of healthy volunteers.

Detailed Description

The objective is to evaluate the effectiveness of the CapScan intestinal collection device in characterizing the regional distribution of sulfasalazine, the metabolic breakdown products of sulfasalazine, and the gut microbiota in the digestive tracts of healthy volunteers.

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2022-10-15
• Study Completion: 2022-10-30
• Study First Submitted: 2023-02-18
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-01
• Results First Submitted: 2023-11-29
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-03
• Last Update Submitted: 2024-02-03
• Results First Posted: 2024-02-06
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit.

Physical Status Classification System 1 or 2. For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit and agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 14 days after the final dose of sulfasalazine.

Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form

Exclusion Criteria

• • Known or suspected gastrointestinal obstructions, strictures or fistula

  • Known or suspected moderate to severe dysmotility, by the judgement of the principal investigator
  • Gastroparesis
  • A swallowing disorder
  • Known intolerance, reaction or hypersensitivity to sulfasalazine, its metabolites, sulfonamides, or salicylates
  • Urinary obstruction
  • Porphyria
  • Glucose-6-phosphate dehydrogenase deficiency
  • Known or suspected infection with severe acute respiratory syndrome, HIV, hepatitis B virus or hepatitis C virus
  • Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding.
  • Use of concomitant medications, such as aspirin, antibiotics, laxatives and proton pump inhibitors that may interfere with the study in the judgement of the investigator.
  • Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the principal investigator, to interfere with the conduct of the study.
  • A clinical condition that, in the judgment of the principal investigator, could potentially pose a health risk to the subject while involved in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	CapScan intestinal sampling device	Open label experimental arm

Primary Outcome Measures

Name	Time	Method
Regional Collection of Metabolites and Gut Microbiota	2 days	Regional measurement of sulfasalazine in the intestinal lumen, the metabolic breakdown products of sulfasalazine and the gut microbiota in the digestive tracts of healthy volunteers.

Trial Locations

Locations (1)

Silicon Valley Gastroenterology; 🇺🇸 Mountain View, California, United States